Family Based Intervention in Childhood obesitY

Randomised Controlled Clinical Trial Comparing Two Family Interventions to Treat Obesity in Children Between 7 and 12 Years.

The study compares the effect on BMI of two different treatment options for obesity in childhood. Families with at least one obese child and parent are invited to join the project. The hypothesis is that family camp gives an additional reduction in BMI compared to a less intensive family lifestyle school.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Parent Management Training - Oregon (PMTO); Behavioral: Motivational interviewing; Behavioral: Dynamic group therapy

Detailed Description

Participants are randomised to two intervention groups:

A): Two weeks family camp and two years follow-up as a cooperation with primary health care, private rehabilitation center and specialist health care.

B): Four days lifestyle school with two years follow-up as a cooperation with primary health care and specialist health care

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • St Olavs hospital
  • Tønsberg, Norway, 3103
    • Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 7 to 12 years
• BMI > iso-BMI 30 (Coles index)

Exclusion Criteria:

• syndromatic obesity
• obesity related to diseases
• local community not involved
• child has present follow-up because of obesity in secondary health care
• parent has present/planned follow-up because of obesity in secondary health care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - family camp; Obese families participate in a two week camp with two years follow-up.	Behavioral: Parent Management Training - Oregon (PMTO); Method to help parents and caregivers manage the behavior of the children they are responsible for.; Behavioral: Motivational interviewing; Communication method to facilitate behavioral change and empower the parents.; Behavioral: Dynamic group therapy; Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.
Other: Group B - family lifestyle school; Families participate in a four day practical course about lifestyle.	Behavioral: Motivational interviewing; Communication method to facilitate behavioral change and empower the parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI-SDS	Primary Outcome Measure is body mass index-standard deviation score. Reduced values from baseline to endpoint means reduced overweight.	After 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Questionnaire for children and parent	After 2 years
Physical fitness	Six minutes walk test for children and parents.	After 2 years
Behaviour	Evaluating effect of intervention on risk for psyciatric disorders.	After 2 years
Blood samples	Improvement in spesific blood tests with relevance to metabolic syndrome after 2 years intervention? Blood is biobanked at baseline and after 2 years.	After 2 years

Collaborators and Investigators

• Sponsor: Sykehuset i Vestfold HF
• Collaborators: Oslo University Hospital; St. Olavs Hospital; Stiftelsen Helse og Rehabilitering; Evjeklinikken; Røros Rehabiliteringssenter; Gjensidigestiftelsen; Organisasjonen Voksne for Barn
• Investigators: Principal Investigator: Samira Lekhal, PhD, MD, The Hospital of Vestfold; Study Chair: Jøran Hjelmesæth, PhD, MD, The Hospital of Vestfold

Publications and helpful links

General Publications

• Benestad B, Karlsen TI, Smastuen MC, Lekhal S, Hertel JK, Steinsbekk S, Kolotkin RL, Odegard RA, Hjelmesaeth J. Health-related quality of life after camp-based family obesity treatment: an RCT. BMJ Paediatr Open. 2019 Apr 3;3(1):e000413. doi: 10.1136/bmjpo-2018-000413. eCollection 2019.
• Benestad B, Lekhal S, Smastuen MC, Hertel JK, Halsteinli V, Odegard RA, Hjelmesaeth J. Camp-based family treatment of childhood obesity: randomised controlled trial. Arch Dis Child. 2017 Apr;102(4):303-310. doi: 10.1136/archdischild-2015-309813. Epub 2016 Nov 2.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 26, 2010

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Child; Family; Obesity; Parent
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: FamilY